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1.
BMJ Open ; 13(8): e072627, 2023 08 03.
Article in English | MEDLINE | ID: mdl-37536960

ABSTRACT

OBJECTIVE: This study investigated the seroprevalence of SARS-CoV-2 antibodies among adults over 18 years. DESIGN: Prospective cohort study. SETTINGS: A large public university. PARTICIPANTS: This study took volunteers over 5 days and recruited 1064 adult participants. PRIMARY OUTCOME MEASURES: Seroprevalence of SARS-CoV-2-specific antibodies due to previous exposure to SARS-CoV-2 and/or vaccination. RESULTS: The seroprevalence of the antireceptor binding domain (RBD) antibody was 90% by a lateral flow assay and 88% by a semiquantitative chemiluminescent immunoassay. The seroprevalence for antinucleocapsid was 20%. In addition, individuals with previous natural COVID-19 infection plus vaccination had higher anti-RBD antibody levels compared with those who had vaccination only or infection only. Individuals who had a breakthrough infection had the highest anti-RBD antibody levels. CONCLUSION: Accurate estimates of the cumulative incidence of SARS-CoV-2 infection can inform the development of university risk mitigation protocols such as encouraging booster shots, extending mask mandates or reverting to online classes. It could help us to have clear guidance to act at the first sign of the next surge as well, especially since there is a surge of COVID-19 subvariant infections.


Subject(s)
COVID-19 , Adult , Humans , Cross-Sectional Studies , Prospective Studies , Seroepidemiologic Studies , Universities , COVID-19/epidemiology , SARS-CoV-2 , Antibodies, Viral
2.
Ann Thorac Surg ; 109(3): 848-855, 2020 03.
Article in English | MEDLINE | ID: mdl-31689407

ABSTRACT

BACKGROUND: The Society of Thoracic Surgeons (STS) General Thoracic Surgery Database (GTSD) has developed composite quality measures for lobectomy and esophagectomy. This study sought to develop a composite measure including all resections for lung cancer. METHODS: The STS lung cancer composite score is based on 2 outcomes: risk-adjusted mortality and morbidity. GTSD data were included from January 2015 to December 2017. "Star ratings" were created for centers with 30 or more cases by using 95% Bayesian credible intervals. The Bayesian model was performed with and without inclusion of the minimally invasive approach to assess the impact of approach on the composite measure. RESULTS: The study population included 38,461 patients from 256 centers. Overall operative mortality was 1.3% (495 of 38,461). The major complication rate was 7.9% (3045 of 38,461). The median number of nodes examined was 10 (interquartile range, 5 to 16); the median number of nodal stations sampled was 4 (interquartile range, 3 to 5). Positive resection margins were identified in 3.7% (1420 of 38,461). A total of 214 centers with 30 or more cases were assigned star ratings. There were 7 1-star, 194 2-star, and 13 3-star programs; 70.6% of resections were performed through a minimally invasive approach. Inclusion of minimally invasive approach, which was adjusted for in previous models, altered the star ratings for 3% (6 of 214) of the programs. CONCLUSIONS: Participants in the STS GTSD perform lung cancer resection with low morbidity and mortality. Lymph node data suggest that participants are meeting contemporary staging standards. There is wide variability among participants in application of minimally invasive approaches. The study found that risk adjustment for approach altered ratings in 3% of participants.


Subject(s)
Carcinoma, Non-Small-Cell Lung/surgery , Lung Neoplasms/surgery , Outcome Assessment, Health Care/methods , Pneumonectomy/standards , Societies, Medical , Thoracic Surgery , Aged , Carcinoma, Non-Small-Cell Lung/diagnosis , Carcinoma, Non-Small-Cell Lung/epidemiology , Female , Humans , Lung Neoplasms/diagnosis , Lung Neoplasms/epidemiology , Male , Morbidity/trends , Neoplasm Staging , Postoperative Complications/epidemiology , Reproducibility of Results , Survival Rate/trends , United States/epidemiology
3.
Ann Thorac Surg ; 107(5): 1302-1306, 2019 May.
Article in English | MEDLINE | ID: mdl-30898564

ABSTRACT

The Society of Thoracic Surgeons General Thoracic Surgery Database (STS GTSD) remains the most robust thoracic surgical database in the world, providing participating institutions semiannual risk-adjusted performance reports and facilitating multiple quality improvement initiatives each year. In 2018, the STS GTSD Data Collection Form was substantially revised to acquire the most important variables with the least data manager burden. In addition, a composite quality measure for all pulmonary resections for cancer was developed, and the impact that minimally invasive approaches have on the model was assessed. The 2018 database audit found that the accuracy of the database remains high, ranging from 92.5% to 98.4%. In 2019, the STS GTSD Task Force plans to focus on increasing generalizability of the database, initiating esophagectomy outcome public reporting, and creating customizable real-time dashboards. This review summarizes all national aggregate outcome, quality measurement, and improvement initiatives from the STS GTSD over the past 12 months.


Subject(s)
Databases, Factual , Outcome Assessment, Health Care , Quality Improvement , Thoracic Surgery , Thoracic Surgical Procedures/statistics & numerical data , Humans , Societies, Medical
4.
Ann Thorac Surg ; 107(1): 202-208, 2019 01.
Article in English | MEDLINE | ID: mdl-30273574

ABSTRACT

BACKGROUND: Parameters defining attainment and maintenance of proficiency in thoracoscopic video-assisted thoracic surgery (VATS) lobectomy remain unknown. To address this knowledge gap, this study investigated the institutional performance curve for VATS lobectomy by using risk-adjusted cumulative sum (Cusum) analysis. METHODS: Using The Society of Thoracic Surgeons General Thoracic Surgery Database, the study investigators identified centers that had performed a total of 30 or more VATS lobectomies. Major morbidity, mortality, and blood transfusion were deemed primary outcomes, with expected incidence derived from risk-adjusted regression models. Acceptable and unacceptable failure rates for outcomes were set a priori according to clinical relevance and informed by regression model output. RESULTS: Between 2001 and 2016, 24,196 patients underwent VATS lobectomy at 159 centers with a median volume of 103 (range, 30 to 760). Overall rates of operative mortality, major morbidity, and transfusion were 1% (244 of 24,189), 17.1% (4,145 of 24,196), and 4% (975 of 24,196), respectively. Of the highest-volume centers (≥100 cases), 84% (65 of 77) and 82 % (63 of 77) (p = 0.48) were proficient by major morbidity standards by their 50th and 100th cases, respectively. Similarly, 92% (71 of 77) and 90% (69 of 77) (p = 0.41) of centers showed proficiency by transfusion standards by their 50th and 100th cases, respectively. Three performance patterns were observed: (1) initial and sustained proficiency, (2) crossing unacceptability thresholds with subsequent improved performance; and (3) crossing unacceptability thresholds without subsequent improved performance. CONCLUSIONS: VATS lobectomy outcomes have improved with lower mortality and transfusion rates. The majority of high-volume centers demonstrated proficiency after 50 cases; however, maintenance of proficiency is not ensured. Cusum provides a simple yet powerful tool that can trigger internal audits and performance improvement initiatives.


Subject(s)
Clinical Competence , Lung Neoplasms/surgery , Pneumonectomy/education , Surgeons/education , Thoracic Surgery, Video-Assisted/education , Aged , Databases, Factual , Female , Humans , Male , Pneumonectomy/standards , Thoracic Surgery, Video-Assisted/standards
5.
Oncogene ; 37(17): 2237-2250, 2018 04.
Article in English | MEDLINE | ID: mdl-29398709

ABSTRACT

Alterations in ERBB family members have been associated with many tumor malignancies. EGFR and ERBB2 have been extensively explored in clinical oncology and several drugs currently target them therapeutically. However, the significance of ERBB4 as a potential therapeutic target remains mostly unexplored, even though ERBB4 is overexpressed or mutated in many solid tumors. Using a unique functional protein microarray platform, we found that ibrutinib inhibits ERBB4 activity in the same nM range as its canonical target, BTK. Cell-based assays revealed that ibrutinib treatment inhibited cell growth and decreased phosphorylation of ERBB4 and downstream targets MEK and ERK in cancer cell lines with high levels of endogenous ERBB4. In vivo, ibrutinib-responsive mouse xenograft tumors showed decreased tumor volumes with ibrutinib treatment. Interestingly, global gene expression comparisons between responsive and non-responsive cells identified a signature featuring the WNT pathway that predicts growth responsiveness to ibrutinib. Non-responsive ERBB4-expressing cell lines featured elevated activity of the WNT pathway, through the overexpression of WNT5A. Moreover, inhibition of WNT5A expression led to an ibrutinib response in non-responsive cell lines. Our data show that inhibiting ERBB4 reduces cell growth in cells that have low WNT5A expression and reveal a link between the ERBB4 and WNT pathways.


Subject(s)
Cell Proliferation/drug effects , Neoplasms/pathology , Pyrazoles/pharmacology , Pyrimidines/pharmacology , Receptor, ErbB-4/antagonists & inhibitors , Wnt-5a Protein/physiology , A549 Cells , Adenine/analogs & derivatives , Animals , Cells, Cultured , Humans , Mice , Mice, Inbred NOD , Mice, SCID , Piperidines , Signal Transduction/drug effects , Signal Transduction/genetics , Tumor Burden/drug effects , Xenograft Model Antitumor Assays
6.
Thorac Surg Clin ; 27(3): 291-296, 2017 Aug.
Article in English | MEDLINE | ID: mdl-28647075

ABSTRACT

Administrative data are less accurate and relevant than specialty-specific, procedure-specific, risk-adjusted data collected in voluntary registries such as the Society of Thoracic Surgeons-General Thoracic Surgery Database (GTSD). Voluntary clinical databases must be proven accurate and complete before they are accepted as credible information sources. With substantial growth of the GTSD, an annual audit was initiated in 2010 to assess the completeness, accuracy, and quality of the data collected. The audit process is essential in validating data quality and adding credibility and value to volunteer clinical registries. It serves as an important tool for improvement of patient care.


Subject(s)
Databases, Factual , Medical Audit , Registries , Thoracic Surgical Procedures , Humans
8.
Ann Thorac Surg ; 103(4): 1063-1069, 2017 Apr.
Article in English | MEDLINE | ID: mdl-27938908

ABSTRACT

BACKGROUND: Various factors may influence outcomes after lobectomy for lung cancer. Postgraduate subspecialty training in general thoracic surgery with a focus on minimally invasive surgery (MIS) and thoracic oncology was completed by an established cardiothoracic surgeon on the hospital staff in July 2007, and principles emphasized in that training were incorporated into practice through formation of a subspecialty program. We hypothesized that establishing a dedicated general thoracic surgeon-lead subspecialty program, with focus on MIS and thoracic oncology, would improve short-term and long-term outcomes. METHODS: Patients entered into the hospital cancer registry have survival status updated annually through correspondence with patients, physicians, and searches of the Social Security Death Index and obituaries. The registry was queried for all patients undergoing lobectomy for lung cancer, 2002 to 2013, and divided into two groups for comparison, before and after, based on operation date relative to January 2008. Patients (n = 279) who had lobectomy for lung cancer were identified in the registry. Data included surgical approach (percent of video-assisted thoracoscopy [VATS]), pathologic stage, number of lymph nodes and stations sampled, hospital length of stay (LOS), and survival. χ2 statistics were used for proportions, t tests for continuous variables, and a nonparametric test for LOS. A Cox proportional hazard model was created, and survival curves were constructed using time between operation and death or last follow-up. RESULTS: Patients having lobectomy in the after group had substantially more VATS procedures (53.9% versus 9.5%), decreased LOS (median 3.5 versus 7.0 days), greater mean total lymph nodes (9.0 versus 6.3), and nodal stations (4.2 versus 2.8) sampled per patient. Thirty-day, 90-day, and 1-year survival were similar in both groups. Overall survival was better in the after group (hazard ratio [HR] 0.41, 95% confidence interval: 0.25 to 0.68), and this survival benefit remained statistically significant when comparing groups stratified by lung cancer stage (stage I: HR 0.46, stage II: HR 0.32, combined stage III to IV: HR 0.19). CONCLUSIONS: Establishing a dedicated general thoracic surgeon-lead subspecialty program, with focus on MIS and thoracic oncology, can substantially improve short-term outcomes with increased VATS utilization, decreased LOS, and increased lymph node sampling. Long-term survival was also significantly improved.


Subject(s)
Lung Neoplasms/surgery , Thoracic Surgery , Adult , Female , Humans , Length of Stay , Lung Neoplasms/mortality , Male , Middle Aged , Neoplasm Staging , Pneumonectomy/methods , Proportional Hazards Models , Registries , Survival Analysis , Thoracic Surgery, Video-Assisted , Treatment Outcome
9.
Ann Thorac Surg ; 102(2): 458-64, 2016 Aug.
Article in English | MEDLINE | ID: mdl-27344280

ABSTRACT

BACKGROUND: Failure to rescue (FTR) is increasingly recognized as an important quality indicator in surgery. The Society of Thoracic Surgeons National Database was used to develop FTR metrics and a predictive FTR model for coronary artery bypass grafting (CABG). METHODS: The study included 604,154 patients undergoing isolated CABG at 1,105 centers from January 2010 to January 2014. FTR was defined as death after four complications: stroke, renal failure, reoperation, and prolonged ventilation. FTR was determined for each complication and a composite of the four complications. A statistical model to predict FTR was developed. RESULTS: FTR rates were 22.3% for renal failure, 16.4% for stroke, 12.4% for reoperation, 12.1% for prolonged ventilation, and 10.5% for the composite. Mortality increased with multiple complications and with specific combinations of complications. The multivariate risk model for prediction of FTR demonstrated a C index of 0.792 and was well calibrated, with a 1.0% average difference between observed/expected (O/E) FTR rates. With centers grouped into mortality terciles, complication rates increased modestly (11.4% to 15.7%), but FTR rates more than doubled (6.8% to 13.9%) from the lowest to highest terciles. Centers in the lowest complication rate tercile had an FTR O/E of 1.14, whereas centers in the highest complication rate tercile had an FTR O/E of 0.91. CONCLUSIONS: CABG mortality rates vary directly with FTR, but complication rates have little relation to death. FTR rates derived from The Society of Thoracic Surgeons data can serve as national benchmarks. Predicted FTR rates may facilitate patient counseling, and FTR O/E ratios have promise as valuable quality metrics.


Subject(s)
Coronary Artery Bypass/adverse effects , Coronary Artery Disease/surgery , Postoperative Complications/epidemiology , Registries , Societies, Medical , Thoracic Surgery , Adult , Cause of Death/trends , Coronary Artery Disease/mortality , Female , Follow-Up Studies , Hospital Mortality/trends , Humans , Incidence , Male , Retrospective Studies , Survival Rate/trends , United States/epidemiology
10.
Ann Thorac Surg ; 102(1): 207-14, 2016 Jul.
Article in English | MEDLINE | ID: mdl-27240449

ABSTRACT

BACKGROUND: The purpose of this analysis was to revise the model for perioperative risk for esophagectomy for cancer utilizing The Society of Thoracic Surgeons General Thoracic Surgery Database to provide enhanced risk stratification and quality improvement measures for contributing centers. METHODS: The Society of Thoracic Surgeons General Thoracic Surgery Database was queried for all patients treated for esophageal cancer with esophagectomy between July 1, 2011, and June 30, 2014. Multivariable risk models for major morbidity, perioperative mortality, and combined morbidity and mortality were created with the inclusion of surgical approach as a risk factor. RESULTS: In all, 4,321 esophagectomies were performed by 164 participating centers. The most common procedures included Ivor Lewis (32.5%), transhiatal (21.7%), minimally invasive esophagectomy, Ivor Lewis type (21.4%), and McKeown (10.0%). Sixty-nine percent of patients received induction therapy. Perioperative mortality (inpatient and 30-day) was 135 of 4,321 (3.4%). Major morbidity occurred in 1,429 patients (33.1%). Major morbidities include unexpected return to operating (15.6%), anastomotic leak (12.9%), reintubation (12.2%), initial ventilation beyond 48 hours (3.5%), pneumonia (12.2%), renal failure (2.0%), and recurrent laryngeal nerve paresis (2.0%). Statistically significant predictors of combined major morbidity or mortality included age more than 65 years, body mass index 35 kg/m(2) or greater, preoperative congestive heart failure, Zubrod score greater than 1, McKeown esophagectomy, current or former smoker, and squamous cell histology. CONCLUSION: Thoracic surgeons participating in The Society of Thoracic Surgeons General Thoracic Surgery Database perform esophagectomy with low morbidity and mortality. McKeown esophagectomy is an independent predictor of combined postoperative morbidity or mortality. Revised predictors for perioperative outcome were identified to facilitate quality improvement processes and hospital comparisons.


Subject(s)
Esophageal Neoplasms/surgery , Esophagectomy , Quality Improvement , Societies, Medical/statistics & numerical data , Thoracic Surgery/statistics & numerical data , Esophageal Neoplasms/mortality , Female , Follow-Up Studies , Humans , Male , Middle Aged , Postoperative Period , Retrospective Studies , Survival Rate/trends , United States/epidemiology
11.
Ann Thorac Surg ; 102(2): 370-7, 2016 Aug.
Article in English | MEDLINE | ID: mdl-27209606

ABSTRACT

BACKGROUND: The Society of Thoracic Surgeons (STS) creates risk-adjustment models for common cardiothoracic operations for quality improvement purposes. Our aim was to update the lung cancer resection risk model utilizing the STS General Thoracic Surgery Database (GTSD) with a larger and more contemporary cohort. METHODS: We queried the STS GTSD for all surgical resections of lung cancers from January 1, 2012, through December 31, 2014. Logistic regression was used to create three risk models for adverse events: operative mortality, major morbidity, and composite mortality and major morbidity. RESULTS: In all, 27,844 lung cancer resections were performed at 231 centers; 62% (n = 17,153) were performed by thoracoscopy. The mortality rate was 1.4% (n = 401), major morbidity rate was 9.1% (n = 2,545), and the composite rate was 9.5% (n = 2,654). Predictors of mortality included age, being male, forced expiratory volume in 1 second, body mass index, cerebrovascular disease, steroids, coronary artery disease, peripheral vascular disease, renal dysfunction, Zubrod score, American Society of Anesthesiologists rating, thoracotomy approach, induction therapy, reoperation, tumor stage, and greater extent of resection (all p < 0.05). For major morbidity and the composite measure, cigarette smoking becomes a risk factor whereas stage, renal dysfunction, congestive heart failure, and cerebrovascular disease lose significance. CONCLUSIONS: Operative mortality and complication rates are low for lung cancer resection among surgeons participating in the GTSD. Risk factors from the prior lung cancer resection model are refined, and new risk factors such as prior thoracic surgery are identified. The GTSD risk models continue to evolve as more centers report and data are audited for quality assurance.


Subject(s)
Lung Neoplasms/surgery , Models, Statistical , Pneumonectomy/methods , Postoperative Complications/epidemiology , Risk Adjustment/methods , Societies, Medical , Thoracic Surgery , Age Factors , Aged , Female , Humans , Incidence , Male , Risk Factors , Sex Factors , Survival Rate/trends , Thoracoscopy/methods , United States/epidemiology
12.
Ann Thorac Surg ; 101(4): 1379-86; discussion 1386-7, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26785936

ABSTRACT

BACKGROUND: The Society of Thoracic Surgeons (STS) has developed multidimensional composite quality measures for common cardiac surgery procedures. This first composite measure for general thoracic surgery evaluates STS participant performance for lobectomy in lung cancer patients. METHODS: The STS lobectomy composite score is composed of two outcomes: risk-adjusted mortality; and any-or-none, risk-adjusted major complications. General Thoracic Surgery Database data were included from 2011 to 2014 to provide adequate sample size, and 95% Bayesian credible intervals were used to determine "star ratings." The STS participants were also compared with national benchmarks (including non-STS participants) using the National Inpatient Sample. Comparisons of discharge mortality, postoperative length of stay, and percent of stage I lung cancers resected using minimally invasive approaches are not included in star ratings but will be reported to participants in STS feedback reports. RESULTS: The study population included 20,657 lobectomy patients from 231 participating centers. Operative mortality was 1.5%, major complication rate was 9.6%, and median postoperative length of stay was 4 days. Risk-adjusted mortality and major complication rates varied threefold from highest performing (three-star) to lowest performing (one-star) programs. Approximately 5% of participants were one-star, 7% were three-star, and 88% were two-star programs. CONCLUSIONS: The STS has developed the first general thoracic surgery quality composite measure to compare programs performing lobectomy for lung cancer. This measure will be used for quality assessment and provider feedback, and will be made available for voluntary public reporting.


Subject(s)
Lung Neoplasms/surgery , Pneumonectomy , Quality Indicators, Health Care , Societies, Medical , Thoracic Surgery, Video-Assisted , Thoracic Surgery , Aged , Cohort Studies , Female , Hospitalization , Humans , Lung Neoplasms/pathology , Male , Middle Aged , Outcome Assessment, Health Care , Pneumonectomy/mortality , Pneumonectomy/statistics & numerical data , Program Evaluation , United States
13.
Ann Thorac Surg ; 101(1): 33-41; discussion 41, 2016 Jan.
Article in English | MEDLINE | ID: mdl-26542437

ABSTRACT

BACKGROUND: The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) has been successfully linked to the Centers for Medicare and Medicaid (CMS) Medicare database, thereby facilitating comparative effectiveness research and providing information about long-term follow-up and cost. The present study uses this link to determine contemporary completeness, penetration, and representativeness of the STS ACSD. METHODS: Using variables common to both STS and CMS databases, STS operations were linked to CMS data for all CMS coronary artery bypass graft (CABG) surgery hospitalizations discharged between 2000 and 2012, inclusive. For each CMS CABG hospitalization, it was determined whether a matching STS record existed. RESULTS: Center-level penetration (number of CMS sites with at least one matched STS participant divided by the total number of CMS CABG sites) increased from 45% in 2000 to 90% in 2012. In 2012, 973 of 1,081 CMS CABG sites (90%) were linked to an STS site. Patient-level penetration (number of CMS CABG hospitalizations done at STS sites divided by the total number of CMS CABG hospitalizations) increased from 51% in 2000 to 94% in 2012. In 2012, 71,634 of 76,072 CMS CABG hospitalizations (94%) occurred at an STS site. Completeness of case inclusion at STS sites (number of CMS CABG cases at STS sites linked to STS records divided by the total number of CMS CABG cases at STS sites) increased from 88% in 2000 to 98% in 2012. In 2012, 69,213 of 70,932 CMS CABG hospitalizations at STS sites (98%) were linked to an STS record. CONCLUSIONS: Linkage of STS and CMS databases demonstrates high and increasing penetration and completeness of the STS database. Linking STS and CMS data facilitates studying long-term outcomes and costs of cardiothoracic surgery.


Subject(s)
Coronary Artery Bypass/statistics & numerical data , Models, Statistical , Societies, Medical/statistics & numerical data , Thoracic Surgery/statistics & numerical data , Aged , Coronary Artery Bypass/economics , Coronary Artery Disease/economics , Coronary Artery Disease/surgery , Costs and Cost Analysis , Female , Follow-Up Studies , Hospitalization/trends , Humans , Male , Medicaid/economics , Medicare/economics , Retrospective Studies , Time Factors , United States
14.
Ann Thorac Surg ; 100(4): 1186-7, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26434428
15.
Ann Thorac Surg ; 100(4): 1315-24; discussion 1324-5, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26330012

ABSTRACT

BACKGROUND: Previous composite performance measures of The Society of Thoracic Surgeons (STS) were estimated at the STS participant level, typically a hospital or group practice. The STS Quality Measurement Task Force has now developed a multiprocedural, multidimensional composite measure suitable for estimating the performance of individual surgeons. METHODS: The development sample from the STS National Database included 621,489 isolated coronary artery bypass grafting procedures, isolated aortic valve replacement, aortic valve replacement plus coronary artery bypass grafting, mitral, or mitral plus coronary artery bypass grafting procedures performed by 2,286 surgeons between July 1, 2011, and June 30, 2014. Each surgeon's composite score combined their aggregate risk-adjusted mortality and major morbidity rates (each weighted inversely by their standard deviations) and reflected the proportion of case types they performed. Model parameters were estimated in a Bayesian framework. Composite star ratings were examined using 90%, 95%, or 98% Bayesian credible intervals. Measure reliability was estimated using various 3-year case thresholds. RESULTS: The final composite measure was defined as 0.81 × (1 minus risk-standardized mortality rate) + 0.19 × (1 minus risk-standardized complication rate). Risk-adjusted mortality (median, 2.3%; interquartile range, 1.7% to 3.0%), morbidity (median, 13.7%; interquartile range, 10.8% to 17.1%), and composite scores (median, 95.4%; interquartile range, 94.4% to 96.3%) varied substantially across surgeons. Using 98% Bayesian credible intervals, there were 207 1-star (lower performance) surgeons (9.1%), 1,701 2-star (as-expected performance) surgeons (74.4%), and 378 3-star (higher performance) surgeons (16.5%). With an eligibility threshold of 100 cases over 3 years, measure reliability was 0.81. CONCLUSIONS: The STS has developed a multiprocedural composite measure suitable for evaluating performance at the individual surgeon level.


Subject(s)
Cardiac Surgical Procedures/statistics & numerical data , Clinical Competence , Adult , Bayes Theorem , Cardiac Surgical Procedures/standards , Coronary Artery Bypass , Humans , Risk Adjustment , Societies, Medical
16.
Ann Surg ; 262(3): 526-35; discussion 533-5, 2015 Sep.
Article in English | MEDLINE | ID: mdl-26258322

ABSTRACT

OBJECTIVES: To evaluate participant characteristics and outcomes during the first 4 years of the Society of Thoracic Surgeons (STS) public reporting program. BACKGROUND: This is the first detailed analysis of a national, voluntary, cardiac surgery public reporting program using STS clinical registry data and National Quality Forum-endorsed performance measures. METHODS: The distributions of risk-adjusted mortality rates, multidimensional composite performance scores, star ratings, and volumes for public reporting versus nonreporting sites were studied during 9 consecutive semiannual reporting periods (2010-2014). RESULTS: Among 8929 unique observations (∼1000 STS participant centers, 9 reporting periods), 916 sites (10.3%) were classified low performing, 6801 (76.2%) were average, and 1212 (13.6%) were high performing. STS public reporting participation varied from 22.2% to 46.3% over the 9 reporting periods. Risk-adjusted, patient-level mortality rates for isolated coronary artery bypass grafting were consistently lower in public reporting versus nonreporting sites (P value range: <0.001-0.0077). Reporting centers had higher composite performance scores and star ratings (23.2% high performing and 4.5% low performing vs 7.6% high performing and 13.8% low performing for nonreporting sites). STS public reporting sites had higher mean annualized coronary artery bypass grafting volumes than nonreporting sites (169 vs 145, P < 0.0001); high-performing programs had higher mean coronary artery bypass grafting volumes (n = 241) than average (n = 139) or low-performing (n = 153) sites. Risk factor prevalence (except reoperation) and expected mortality rates were generally stable during the study period. CONCLUSIONS: STS programs that voluntarily participate in public reporting have significantly higher volumes and performance. No evidence of risk aversion was found.


Subject(s)
Access to Information , Hospital Mortality/trends , Information Dissemination , Quality Assurance, Health Care , Thoracic Surgery/organization & administration , Adult , Aged , Coronary Artery Bypass/methods , Coronary Artery Bypass/mortality , Coronary Artery Bypass/statistics & numerical data , Databases, Factual , Female , Humans , Male , Middle Aged , Risk Assessment , Societies, Medical , Survival Analysis , Time Factors , Treatment Outcome , United States
17.
Anal Chem ; 86(19): 9860-5, 2014 Oct 07.
Article in English | MEDLINE | ID: mdl-25153794

ABSTRACT

We report on a quantitative study of small molecule binding kinetics on protein microarrays with plasmonic-based electrochemical impedance microscopy (P-EIM). P-EIM measures electrical impedance optically with high spatial resolution by converting a surface charge change to a surface plasmon resonance (SPR) image intensity change, and the signal is not scaled to the mass of the analyte. Using P-EIM, we measured binding kinetics and affinity between small molecule drugs (imatinib and SB202190) and their target proteins (kinases Abl1 and p38-α). The measured affinity values are consistent with reported values measured by an indirect competitive binding assay. We also found that SB202190 has weak bindings to ABL1 with KD > 10 µM, which is not reported in the literature. Furthermore, we found that P-EIM is less prone to nonspecific binding, a long-standing issue in SPR. Our results show that P-EIM is a novel method for high-throughput measurement of small molecule binding kinetics and affinity, which is critical to the understanding of small molecules in biological systems and discovery of small molecule drugs.


Subject(s)
Benzamides/chemistry , Imidazoles/chemistry , Mannose-Binding Lectin/chemistry , Mitogen-Activated Protein Kinase 14/chemistry , Molecular Imaging/methods , Piperazines/chemistry , Proto-Oncogene Proteins c-abl/chemistry , Proto-Oncogene Proteins c-kit/chemistry , Pyridines/chemistry , Pyrimidines/chemistry , Electric Impedance , Humans , Imatinib Mesylate , Kinetics , Molecular Imaging/instrumentation , Protein Array Analysis , Protein Binding , Surface Plasmon Resonance
18.
Oncology ; 87(1): 21-9, 2014.
Article in English | MEDLINE | ID: mdl-24968881

ABSTRACT

Therapies for advanced hepatocellular carcinoma (HCC) are limited. We carried out a phase I trial of a novel autologous whole-cell tumor cell immunotherapy (FANG™), which incorporates a dual granulocyte macrophage colony-stimulating factor (GM-CSF) expressive/bifunctional small hairpin RNA interference (bi-shRNAi) vector. The bi-shRNAi DNA targets furin, which is a proconvertase of transforming growth factors beta (TGFß) 1 and 2. Safety, mechanism, immunoeffectiveness, and suggested benefit were previously shown [Senzer et al.: Mol Ther 2012;20:679-689; Senzer et al.: J Vaccines Vaccin 2013;4:209]. We now provide further follow-up of a subset of 8 HCC patients. FANG manufacturing was successful in 7 of 8 attempts (one failure due to insufficient cell yield). Median GM-CSF expression was 144 pg/10(6) cells, TGFß1 knockdown was 100%, and TGFß2 knockdown was 93% of the vector-transported cells. Five patients were vaccinated (1 or 2.5×10(7) cells/intradermal injection, 6-11 vaccinations). No FANG toxicity was observed. Three of these patients demonstrated evidence of an immune response to the autologous tumor cell sample. Long-term follow-up demonstrated survival of 319, 729, 784, 931+, and 1,043+ days of the FANG-treated patients. In conclusion, evidence supports further assessment of the FANG immunotherapy in HCC.


Subject(s)
Cancer Vaccines/administration & dosage , Carcinoma, Hepatocellular/therapy , Granulocyte-Macrophage Colony-Stimulating Factor/genetics , Liver Neoplasms/therapy , RNA, Small Interfering/genetics , Vaccination , Adult , Aged , Carcinoma, Hepatocellular/immunology , Carcinoma, Hepatocellular/mortality , Carcinoma, Hepatocellular/pathology , Female , Gene Expression , Gene Knockdown Techniques , Granulocyte-Macrophage Colony-Stimulating Factor/biosynthesis , Humans , Injections, Intradermal , Liver Neoplasms/immunology , Liver Neoplasms/mortality , Liver Neoplasms/pathology , Male , Middle Aged , Survival Analysis , Transforming Growth Factor beta1/genetics , Transforming Growth Factor beta1/metabolism , Transforming Growth Factor beta2/genetics , Transforming Growth Factor beta2/metabolism , Transplantation, Autologous , Treatment Outcome
19.
JAMA Intern Med ; 174(8): 1320-7, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24934977

ABSTRACT

IMPORTANCE: Use of preoperative ß-blockers has been associated with a reduction in perioperative mortality for patients undergoing coronary artery bypass grafting (CABG) surgery in observational research studies, which led to the adoption of preoperative ß-blocker therapy as a national quality standard. OBJECTIVE: To determine whether preoperative ß-blocker use within 24 hours of CABG surgery is associated with reduced perioperative mortality in a contemporary sample of patients. DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of the Society of Thoracic Surgeons National Adult Cardiac database for 1107 hospitals performing cardiac surgery in the United States from January 1, 2008, through December 31, 2012. Participants included 506,110 patients 18 years and older undergoing nonemergent CABG surgery who had not experienced a myocardial infarction in the prior 21 days or any other high-risk presenting symptom. We used logistic regression and propensity matching with a greedy 5-to-1 digit-matching algorithm to examine the association between ß-blocker use and the main outcomes of interest. EXPOSURES: Preoperative ß-blocker use. MAIN OUTCOMES AND MEASURES: Incidence of perioperative mortality, permanent stroke, prolonged ventilation, any reoperation, renal failure, deep sternal wound infection, and atrial fibrillation. RESULTS: Among the 506,110 patients undergoing CABG surgery who met the inclusion criteria, 86.24% received preoperative ß-blockers within 24 hours of surgery. In propensity-matched analyses that included 138,542 patients, we found no significant difference between patients who did and did not receive preoperative ß-blockers in rates of operative mortality (1.12% vs 1.17%; odds ratio [OR], 0.96 [95% CI, 0.87-1.06]; P = .38), permanent stroke (0.97% vs 0.98%; OR, 0.99 [95% CI, 0.89-1.10]; P = .81), prolonged ventilation (7.01% vs 6.86%; OR, 1.02 [95% CI, 0.98-1.07]; P = .26), any reoperation (3.60% vs 3.69%; OR, 0.97 [95% CI, 0.92-1.03]; P = .35), renal failure (2.33% vs 2.24%; OR, 1.04 [95% CI, 0.97-1.11]; P = .30), and deep sternal wound infection (0.29% vs 0.34%; OR, 0.86 [95% CI, 0.71-1.04]; P = .12). However, patients who received preoperative ß-blockers within 24 hours of surgery had higher rates of new-onset atrial fibrillation when compared with patients who did not (21.50% vs 20.10%; OR, 1.09 [95% CI, 1.06-1.12]; P < .001). Results of logistic regression analyses were broadly consistent. CONCLUSIONS AND RELEVANCE: Preoperative ß-blocker use among patients undergoing nonemergent CABG surgery who have not had a recent myocardial infarction was not associated with improved perioperative outcomes.


Subject(s)
Adrenergic beta-Antagonists/therapeutic use , Atrial Fibrillation/epidemiology , Coronary Artery Bypass/methods , Postoperative Complications/epidemiology , Preoperative Care/methods , Renal Insufficiency/epidemiology , Respiration, Artificial/statistics & numerical data , Stroke/epidemiology , Adult , Aged , Cohort Studies , Coronary Artery Bypass/mortality , Databases, Factual , Female , Humans , Incidence , Logistic Models , Male , Middle Aged , Odds Ratio , Perioperative Period , Propensity Score , Protective Factors , Reoperation/statistics & numerical data , Retrospective Studies , Surgical Wound Infection/epidemiology , United States
20.
Ann Thorac Surg ; 96(5): 1734-9; discussion 1738-9, 2013 Nov.
Article in English | MEDLINE | ID: mdl-23998406

ABSTRACT

BACKGROUND: The Society of Thoracic Surgeons (STS) General Thoracic Surgery Database (GTSD) reports outstanding results for lung and esophageal cancer resection. However, a major weakness of the GTSD has been the lack of validation of this voluntary registry. The purpose of this study was to perform an external, independent audit to assess the accuracy of the data collection process and the quality of the database. METHODS: An independent firm was contracted to audit 5% of sites randomly selected from the GTDB in 2011. Audits were performed remotely to maximize the number of audits performed and reduce cost. Auditors compared lobectomy cases submitted to the GTSD with the hospital operative logs to evaluate completeness of the data. In addition, 20 lobectomy records from each site were audited in detail. Agreement rates were calculated for 32 individual data elements, 7 data categories pertaining to patient status or care delivery, and an overall agreement rate for each site. Six process variables were also evaluated to assess best practice for data collection and submission. RESULTS: Ten sites were audited from the 222 participants. Comparison of the 559 submitted lobectomy cases with operative logs from each site identified 28 omissions, a 94.6% agreement rate (discrepancies/site range, 2 to 27). Importantly, cases not submitted had no mortality or major morbidity, indicating a lack of purposeful omission. The aggregate agreement rates for all categories were greater than 90%. The overall data accuracy was 94.9%. CONCLUSIONS: External audits of the GTSD validate the accuracy and completeness of the data. Careful examination of unreported cases demonstrated no purposeful omission or gaming. Although these preliminary results are quite good, it is imperative that the audit process is refined and continues to expand along with the GTSD to insure reliability of the database. The audit results are currently being incorporated into educational and quality improvement processes to add further value.


Subject(s)
Databases, Factual , Thoracic Surgery , Societies, Medical , United States
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